MAUDE Adverse Event Report: ABBOTT MEDICAL TRICLIP G4 SYSTEM; TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED

Model Number	TCDS0301-XTW
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	Tricuspid Valve Insufficiency/ Regurgitation (4453)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a patient presented with grade 4 functional tricuspid regurgitation (tr) for a triclip procedure.During the procedure, two triclips were implanted successfully.Imaging was difficult.The final tr was grade 1.There were no adverse patient effects or clinically significant delays reported.On (b)(6) 2025 follow up, it was determined that a single leaflet device attachment has occurred for the second clip and clip was no longer attached to the anterior leaflet.Per the physician, slda was due to the pre-existing patient anatomy.Tr was grade 2 after slda.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.Based on available information, the cause of the reported single leaflet device attachment (slda) appears to be due to challenging patient anatomy.The cause of the reported difficult imaging could not be determined.The reported recurrent tricuspid regurgitation was a cascading effect of the slda.Tricuspid regurgitation (tr) is a listed in the instructions for use as known possible complications associated with the triclip procedures.The reported serious injury/ illness/ impairment was the result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: TRICLIP G4 SYSTEM
• Common Device Name: TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24717916
• Report Number: 2135147-2026-01971
• Device Sequence Number: 5726613
• Product Code: NPS
• UDI-Device Identifier: 05415067047755
• UDI-Public: (01)05415067047755(17)260112(10)50110R1099
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P230007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2026
• Device Model Number: TCDS0301-XTW
• Device Catalogue Number: TCDS0301-XTW
• Device Lot Number: 50110R1099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Weight: 76 KG